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Sr Director, CMC Regulatory Affairs –Small MoleculesKEY RESPONSIBILITIESThe Sr Director, CMC Regulatory Affairs for Small Molecules is responsible for managing a team of professionals, who work with Gilead’s global portfolio of small molecule products in CMC Regulatory Affairs.
$237,660 - $307,560ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
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Meta is seeking a highly motivated, organized, detail-oriented candidate to assist the Payments Compliance Team as an Investigator on the Transaction Monitoring Team. The Transaction Monitoring team manages reviews of platform transaction activity for potential red flag identification and regulatory reporting.
$90,000 - $137,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Hands on testing experience for EMC/EMI/RF regulatory compliance including FCC/ISED, supporting applications like BT, WLAN/Wifi, NFC, 802.11, LTE. Experience working in the RF/Wireless, TCB, ICT, Appliance, Electronics in product regulatory and/or product development capacities.
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This role will interact with cross-functional teams, including colleagues from Clinical Operations, Biostatistics, Clinical Data Management, Medical Affairs, Regulatory Affairs, Research and others.
$245,000 - $327,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
$99,361 - $136,621 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Strong understanding of drug discovery and development processes, including preclinical, clinical, and regulatory requirements. You will be responsible for driving the success of our strategic partnerships (Amgen, Astellas, Bristol Myers Squibb, Regeneron, and Moderna) and portfolio initiatives while embodying and modeling the core values of CytomX Therapeutics.
$250,000 - $290,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities.
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Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP.
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Author and review Precision Medicine related sections in clinical study / regulatory documents (i.e. INDs, IBs, trial protocols/ops manuals, ICFs, IRB responses, HA Briefing Books, CSRs, etc) Ensure that overall budget, schedule, and performance standards are attained, and be accountable for the overall Precision Medicine strategy in oncology clinical studies, in compliance with AbbVie’s processes and regulatory requirements.
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Obtain Licenses: Become a FINRA (Financial Industry Regulatory Authority) Registered Representative by studying for and obtaining your SIE, Series 7 Top Off and Series 66 licenses, fully paid for and sponsored by Fidelity.
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TA specialist collaborates with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, and commercial, to manage global response topics and content.
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5+ years experience in role/s operationalizing data policies - e.g. data privacy operations, privacy regulatory compliance, security GRC, Trust & Safety function - executing cross-functional organizational processes in data governance/ digital transformation.
$140,700 - $211,100 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13." Stays current with industry trends and best practices with respect to clinical supply management as well as changes in the regulatory landscape that would impact clinical supply chain.
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Knowledgeable in IT compliance and regulatory standards, such as SOX compliance. Ensure compliance with regulatory standards including SOX, focusing on the SaaS portfolio, network, security and data protection.
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regulatory affairs jobs Title: sr Company: Csl Behring in San Mateo, CA
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